In the continuing saga of social media guidance ...
AstraZeneca (NYSE: AZN) today asked the U.S. Food and Drug Administration (FDA) to adopt guidance that will enable AstraZeneca and others to fully engage in real-time, social media conversations that responsibly provide accurate, balanced information on medicines from a known, identifiable and reliable source.
AstraZeneca’s proposal was in response to the FDA's September 2009 Call for Comments on their public notice: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.
“AstraZeneca understands the value of social media to engage key stakeholders in today’s technology-driven world,” said Bob Perkins, Vice President, Public Policy and Promotional Affairs. “While we have developed a corporate presence in the digital space, we believe it is increasingly important to participate in online channels to provide accurate and regulated information about our branded products in conversations with patients, caregivers, and health care providers.”
AstraZeneca believes that five principles should be at the core of any company engagement in social media:
- Truth and Accuracy: Content must be created, developed, or made available that is truthful, balanced, accurate, and not misleading.
- To Be Respectful: Encourage product sponsor participation that respects the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship.
- Protect and Advance Patient Health: Facilitate patient access to quality information for use with their physician to improve their health and protect patients through encouraging accurate and timely reporting on medicine safety.
- Transparency: Any product sponsor participation should be accomplished in a manner that, at all times, is entirely transparent to other participants as to the role of product sponsors as participants in online discussion.
- Respect the Views of Others: Acknowledge that patients, caregivers, clinicians and others who participate in social media have their own opinions and that, when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views but to add the product sponsor’s own views to the discussion.
In its comments to the FDA, AstraZeneca proposed a regulatory framework that is consistent with these principles and defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media:
- Company-controlled, hosted online communications
- Company-controlled communications
- Real-time, social media participation communications
The company also noted that, “Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making. In our absence, consumers will turn to information sources that are not regulated and not always well informed.”
AstraZeneca believes the company has an obligation to participate in social media in a responsible way to help educate and empower patients, caregivers and prescribers to make informed decisions about its products.
Click here to view AstraZeneca’s full submission: http://www.astrazeneca-us.com/_mshost795281/content/media/FDA-2009-N-0441.pdf
